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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Greaves, Ronda / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter


IMPACT FACTOR 2017: 3.556

CiteScore 2018: 2.44

SCImago Journal Rank (SJR) 2018: 1.191
Source Normalized Impact per Paper (SNIP) 2018: 1.205

Online
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1437-4331
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Volume 49, Issue 7

Issues

Harmonization of growth hormone measurements with different immunoassays by data adjustment

Anne Müller
  • Institute of Laboratory Medicine, Clinical Chemistry and Molecular Diagnostics, University of Leipzig, Leipzig, Germany
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/ Markus Scholz
  • Institute for Medical Informatics, Statistics and Epidemiology, University of Leipzig, Leipzig, Germany
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/ Oliver Blankenstein / Gerhard Binder / Roland Pfäffle / Antje Körner / Wieland Kiess / Annegret Heider / Martin Bidlingmaier
  • Department of Internal Medicine (Endocrinology)-Innenstadt, University of Munich, Munich, Germany
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/ Joachim Thiery
  • Institute of Laboratory Medicine, Clinical Chemistry and Molecular Diagnostics, University of Leipzig, Leipzig, Germany
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/ Jürgen Kratzsch
  • Institute of Laboratory Medicine, Clinical Chemistry and Molecular Diagnostics, University of Leipzig, Leipzig, Germany
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Published Online: 2011-06-01 | DOI: https://doi.org/10.1515/CCLM.2011.201

Abstract

Background: The aim of our study was to evaluate the between-assay variability of commercially available immunoassays for the measurement of human growth hormone (hGH). In addition, we asked whether the comparability of the diagnosis of childhood onset growth hormone deficiency could be improved by adjusting hGH results by statistical methods, such as linear regression, conversion factors, and quantile transformation.

Methods: In archived sera from 312 children and adolescents (age: 17 days–17 years) hGH values between 0.01 and 16.5 ng/mL were determined by using the following immunoassays: AutoDELFIA (PerkinElmer), BC-IRMA (Beckman-Coulter), ELISA (Mediagnost), IMMULITE 2000 (Siemens), iSYS (IDS), Liaison (DiaSorin), UniCel DxI 800 Access (BeckmanCoulter) and “In house”-RIA (Tübingen).

Results: The assays differed in median hGH concentrations by as much as 5.44 ng/mL (Immulite), and as little as 2.67 ng/mL (BC-IRMA). The mean difference between assays ranged from 0.35 to 2.71 ng/mL, whereas several samples displayed differences up to 11.4 ng/mL. The best correlation (r=0.992) was found between AutoDELFIA and Liasion, the lowest (r=0.864) was between an in-house RIA and iSYS. The between-assay CV (mean±SD) of values within the cut-off range was 24.3%±7.4%, resulting in an assay-dependent diagnosis of growth hormone deficiency (GHD) in more than 27% of patients. Yet, adjustment of this data by linear regression or a conversion factor reduced the CV below 14%, and the ratio of assay-dependent diagnoses below 8%. Using quantile transformation, the CV and ratio were reduced to 11.4% and <1%, respectively.

Conclusions: hGH measurements using different assays vary significantly. Linear regression, conversion factors, or particularly quantile transformation are useful tools to improve comparability in the diagnostic procedure for the confirmation of GHD in childhood and adolescence.

Keywords: adolescents; children; growth hormone deficiency; immunoassay; short stature

About the article

Corresponding author: Prof. Dr. rer. nat. Jürgen Kratzsch, University of Leipzig, Institute of Laboratory Medicine, Clinical Chemistry and Molecular Diagnostics, Paul-List-Str. 13–15, 04103 Leipzig, Germany Phone: +49 341 97 222 41


Received: 2010-11-18

Accepted: 2011-03-06

Published Online: 2011-06-01

Published in Print: 2011-07-01


Citation Information: Clinical Chemistry and Laboratory Medicine, Volume 49, Issue 7, Pages 1135–1142, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/CCLM.2011.201.

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